EP3363409B1

EP3363409B1 - Length extensible implantable device and methods for making such devices

Info

Publication number: EP3363409B1
Application number: EP18167101.7A
Authority: EP
Inventors: Edward H Cully; Jeffrey B DUNCAN
Original assignee: WL Gore and Associates Inc
Current assignee: WL Gore and Associates Inc
Priority date: 2013-12-05
Filing date: 2014-12-03
Publication date: 2022-05-04
Anticipated expiration: 2034-12-03
Also published as: EP3076899A1; US20210138121A1; HK1258052A1; US10842918B2; EP3076899B1; US20150157770A1; ES2924201T3; WO2015084995A1; US11911537B2; EP3363409A1

Description

TECHNICAL FIELD

This disclosure relates to length extensible implantable devices and methods for making such devices that may be used for providing a lumen for fluid flow in bodily cavities, organs, and vessels within a patient.

BACKGROUND

Medical devices are frequently used to treat the anatomy of patients. Such devices can be permanently or semi-permanently implanted in the anatomy to provide treatment to a patient. Frequently, these devices, including stents, grafts, stent-grafts, filters, valves, occluders, markers, mapping devices, therapeutic agent delivery devices, prostheses, pumps, bandages, and other endoluminal and implantable devices, are inserted into the body at an insertion point and delivered to a treatment site using a catheter.
Implantable devices such as grafts and stent-grafts are used in a variety of places in the human body to repair, support, and/or replace anatomical lumens, such as blood vessels, respiratory ducts, gastrointestinal ducts, and the like. Such devices can, for example, provide lumens for blood flow. In such configurations, flexible and durable devices are needed.
The selection of such implantable devices can pose potential issues. For example, the particularities of the anatomy of one patient may require a device having a different length than a device suitable for another patient. As a result, it may be difficult to determine the necessary size of a device, and, in many instances, the desired device size may be difficult to obtain.
US5843171 discloses a tube of porous PTFE having at least two first and at least two second regions wherein the at least two first regions have a greater density than the at least two second regions. For tubes of porous expanded PTFE having a microstructure of nodes interconnected by fibrils, the at least two first regions have a mean fibril length that is less than that of the at least two second regions. Preferably the regions are arranged in the form of ring-shaped segments of the tube wherein denser segments alternate along the length of the tube with less dense segments.
WO 2006/058322 discloses a prothetic implantable device that offers a reduction in fluid loss when the device is puntured, such as by a dialysis needle or suture needle, and the needle is subsequently removed. The device includes inner and outer layers of a porous material having a microstructure of nodes interconnected by bent fibrils, and having void spaces between adjacent bent fibrils. The inner and outer layers are joined by an elastomeric adhesive that may interpenetrate the void spaces between adjacent bent fibrils.
WO 99/26558 discloses a tubular device for carrying liquids or gases that is resistant to leakage following puncture. The tubular device employs two or more concentrically mounted tube elements that are adapted to move relative to one another following puncture and removal of the puncturing device.
WO 03/003946 discloses an ePTFE material and method of preparing an ePTFE material which is formed from the steps comprising longitudinally expanding a PTFE tubular structure to provide a first node and fibril orientation and subjecting said first node and fibril orientation to a radially expansive and longitudinal foreshortening force to form a second node and fibril orientation whereby fibrils have been hingeably rotated about the nodes.
EP0775472A2 discloses an expandable stent-graft generally defining a cylindrical lumen made from a stent having a discontinuous wall that is at least substantially covered with an expanded polytetrafluoroethylene material. The expanded polytetrafluoroethylene covering may be a biaxially oriented, expanded polytetrafluoroethylene material having nodules and longitudinal and circumferential fibrils or a uniaxially oriented, expanded polytetrafluoroethylene material. The expandable stent-graft expands and compresses in association with the stent structure as it is contracted and expanded.
WO96/07370A1 discloses an asymmetrical form of porous PTFE having substantially different dimensions at different points along the length of the form. If the form is, for example, a tubular form, the different dimensions may be thickness or diameter or both. The form is preferably a tubular form which is preferably tapered having opposing ends with large and small inside diameters respectively wherein the wall thickness of the large diameter end is greater than or equal to the wall thickness of the small diameter end. Tapered PTFE tubes of this type are particularly useful as implantable vascular grafts. A method of producing these asymmetrical porous PTFE forms is also described.
WO94/13224A1 discloses a vascular graft in the form of a tube or flat sheet of biocompatible material having an outer covering of deflectably secured material such as porous film, fibers, discrete pieces of material, or combinations thereof. Two different types of fibers may also be used.
US2002/198588A1 discloses an improved endovascular device particularly useful for use in transjugular intrahepatic portosystemic shunt (TIPS) procedures. The device employs a two-part stent-graft construction that provides a low permeability membrane to line the shunt and an uncovered stent portion designed to reside in the portal vein.
As such, there is an ongoing need to provide devices, such as grafts and/or stent-grafts, which have adjustable length properties to provide a range of available lengths. Such devices may improve the ability of a treatment provider to properly size a device for the anatomy of a patient.

SUMMARY

In a first general aspect, the invention refers to an implantable device in accordance with claim 1.
In a second general aspect, the invention refers to a method for making an implantable device in accordance with claim 2.
The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and the drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Figs. 1A - 1C are perspective views of various length extensible implantable devices in accordance with the present disclosure;
Figs. 2A and 2B are schematic representations of a microstructure of ePTFE material of the prior art;
Fig. 3 is a perspective view of a length extensible implantable device in accordance with the present disclosure;
Fig. 4 is a perspective view of another length extensible implantable device in accordance with the present disclosure; and
Figs. 5A - 5D are perspective views of a length extensible implantable device in various stages.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF THE DRAWINGS

This disclosure describes devices, systems, and methods that are useful, for example, for repairing, supporting, and/or replacing anatomical lumens. Several implantable medical devices are described herein, and in general any of the features described with respect to a particular device may also be used with any of the other devices described herein. In some examples, one or more features described with respect to a particular device may be added to or included with another device. Also, various combinations or sub-combinations of any of the features described herein may generally be used with any of the devices described herein.
In general, any of the implantable devices described herein can be delivered to, and deployed at, an in vivo deployment site within a body of a patient using variously minimally invasive surgical techniques. Likewise, these devices may also be surgically implanted via vascular surgical techniques.
Further, any of the implantable medical devices described herein can be delivered to, and deployed at, an in vivo deployment site within a body of a patient using various minimally invasive transcatheter deployment techniques. For example, any of the implantable medical devices described herein may be releasably attached to a delivery catheter, and the device and delivery catheter may be loaded into a delivery sheath. The delivery sheath may be introduced to the vasculature of the patient and advanced through the vasculature, until a distal end of the delivery sheath is located at or near the target in vivo deployment site. The implantable medical device may be deployed at the deployment site, for example, by retracting the delivery sheath and/or advancing the delivery catheter and the implantable medical device and detaching the implantable medical device from the delivery catheter. The delivery catheter and delivery sheath can then be withdrawn or retracted from the body of the patient.
Any of the implantable medical devices discussed herein can be used to repair, replace, and/or provide support to a body lumen. In various embodiments, implantable medical devices of the present disclosure can be used in a body lumen, including those within the circulatory and gastrointestinal systems.
As used herein, "implantable" means implanted in the body of a patient for more than 29 days.
As used herein, the term "constrain" means: (i) to limit extension, occurring either through self-expansion or assisted expansion, of the length of an implantable device; or (ii) to cover or surround, but not otherwise restrain, an implantable device such as for storage or biocompatibility reasons and/or to provide protection to the implantable device and/or the vasculature.
Figs. 1A-1C describe perspective views of various example length extensible implantable devices 100 comprising a porous tubular member 102 and a longitudinal constraining member 104. Length extensible implantable device 100 can be implanted in the body of a patient either alone or in combination with one or more other components. For example, length extensible implantable device 100 can be combined with a suitable stent, forming a stent-graft. Further, length extensible implant 100 can be combined with other grafts and/or stent-grafts. In other embodiments, the length extensible graft 100 may be provided with a stent (or stent graft) on only one end or alternatively on more than one end or even each end of the length extensible graft 100. A stent graft is considered to be a stent provided with a graft covering all or a portion of the inner or outer surfaces of the stent or both the inner and outer surfaces of the stent. Devices with more than two ends are also contemplated, such as bifurcated devices. Any combination of length extensible implantable device 100 with any suitable medical device is within the scope of the present disclosure.
In various embodiments, porous tubular member 102 is a porous ePTFE member. It is also appreciated that these types of materials may be provided with coatings such as elastomeric coatings and coatings including therapeutic agents (e.g., heparin). Coatings may be provided as surface coatings or alternatively may partially or entirely impregnate the porous materials.
Porous tubular member 102 can, for example, comprise an ePTFE construct. In various embodiments, porous tubular member 102 comprises a longitudinally extruded and longitudinally expanded ePTFE tube, such as the tubes described in U.S. Pat. Nos. 3,953,566 and 4,187,390 . In other embodiments, polymeric tubular member 102 comprises a wrapped ePTFE film tube. For example, member 102 can comprises a tube made from an ePTFE film that has been cigarette wrapped on the surface of a mandrel or, alternatively, has been helically wrapped on the surface of a mandrel. Such ePTFE films of this type can be made generally as taught by U.S. Pat. Nos. 3,953,566 and 4,187,390 . Likewise, conventional longitudinally extruded and expanded ePTFE tubes may be usefully reinforced with an external wrap of ePTFE film, typically, a helical wrap. However, any suitable porous ePTFE tubular member is within the scope of the present disclosure.
In various embodiments, porous tubular member 102 comprises an ePTFE tube having a multiplicity of fibrils which in turn can be connected to a multiplicity of nodes. The microstructure of porous tubular member 102 can comprise a multiplicity of fibrils having a mean fibril length. Mean fibril length can be determined, for example, by examining a photomicrograph of the surface of porous tubular member 102 and by taking the mean of ten measurements made in the predominant direction of the fibrils between nodes connected by fibrils. First, a photomicrograph is made of a representative region of the sample surface, of adequate magnification to show at least five sequential fibrils within the length of the photomicrograph. A series of five measurements are taken along a straight line drawn across the surface of the photomicrograph in the predominant direction of the fibrils followed by a second series of five measurements made along a second line drawn parallel to the first. A measurement constitutes the distance between adjacent nodes connected by at least one fibril. The ten measurements obtained by this method are meant to obtain the mean fibril length of the region.
For example, as illustrated in Figs.. 2A and 2B, porous tubular member 102 can comprise a microstructure of nodes 212, 222 interconnected by fibrils 214, 224.
In various embodiments, in the longitudinally uncompressed configuration, porous tubular member 102 can comprise a multiplicity of straight or unbent fibrils 214. Similarly, visual observation of a magnified longitudinal cross section of porous tubular member 102 indicates that a majority of the fibrils straight or unbent.
For example, after longitudinal compression, portion 110 of porous tubular member 102 comprises a multiplicity of bent fibrils 224. Similarly, visual observation of a magnified longitudinal cross section of portion 110 can indicate that a majority of the fibrils 224 connected to nodes 222 are relatively straight or unbent.
In various embodiments, at least a portion of porous tubular member 102 is held in a longitudinally compressed configuration by longitudinal constraining member 104. As illustrated in Figs. 1A-1C, in such configurations, longitudinal constraining member 104 can surround a portion 110 of an abluminal surface of porous tubular member 102 and maintain portion 110 in the longitudinally compressed configuration. In various embodiments, portion 110 is the entire length of porous tubular member 102.
In various embodiments, portion 110 of porous tubular member 102, when compressed to the laterally compressed configuration, comprises a multiplicity of bent fibrils. In such embodiments, the mean fibril length in portion 110 is shorter than the mean fibril length of porous tubular member 102 in the initial, longitudinally uncompressed configuration. Further, visual observation of a magnified surface of portion 110 can indicate that a majority of the fibrils are relatively non-parallel and bent in relation to the longitudinal axis of the tubular member.
Longitudinal constraining member 104 is capable of rupturing when force
is applied in a particular direction. For example, in configurations in which a portion 110 of porous tubular member 102 is held in the longitudinal compressed configuration, applying tension to one or both ends of porous tubular member can cause longitudinal constraining member 104 to rupture. Rupture of longitudinal constraining member 104 can permit portion 110 to extend from the longitudinally compressed configuration to a less compressed configuration having fibrils that are less bent.
In other examples, longitudinal constraining member 104 can be ruptured by applying a radial force. For example, a balloon can be used to apply radial force to porous tubular member 102, rupturing longitudinal constraining member 104 and permitting extension of portion 110 to a lesser compressed configuration having fibrils that are less bent.
With reference to Figs. 1A - 1C, in various embodiments, longitudinal constraining member 104 can comprise a variety of different tubular forms. For example, longitudinal constraining member 104 can comprise an ePTFE film. In various embodiments, longitudinal constraining member 104 comprises an ePTFE film having a multiplicity of nodes connected by fibrils, such as those taught by U.S. Pat. Nos. 3,953,566 , 4,187,390 , and 5,814,405 .
Fig. 1A illustrates a film wrapped around the surface of porous tubular member 102 at a low angle in relation to a longitudinal axis of the porous tubular member. For example, the film can be wrapped between about 0° and 45° relative to the longitudinal axis of porous tubular member 102.
In various embodiments, as illustrated in Fig. 1B, longitudinal constraining member 104 can comprise a film wrapped around the surface of porous tubular member 102 at a higher angle in relation to the longitudinal axis of the porous tubular member. For example, the film can be wrapped between about 45° and 90° relative to the longitudinal axis of porous tubular member 102.
In yet other embodiments, longitudinal constraining member 104 can comprise a tubular member capable of rupturing upon the application of a sufficiently large force. Such a tubular member can comprise a tubular wall having a multiplicity of slits, holes, and/or perforations that facilitate rupturing. As illustrated in Fig. 1C, longitudinal constraining member 104 can comprise, for example, a perforated tube.
As illustrated in the perspective view of Fig. 3, implantable device 100 can comprise a first longitudinal constraining member 104 and a second longitudinal constraining member 334. For example, first longitudinal constraining member 104 can surround a first portion 110 of porous tubular member 102, and second longitudinal constraining member 334 can surround a second portion 330 of porous tubular member 102.
In various embodiments, first portion 110 and second portion 330 can comprise at least a part of the same portion, such that second longitudinal constraining member 334 surrounds first longitudinal constraining member 104. For example, the perspective view of Fig. 4 illustrates second longitudinal constraining member 334 surrounding second portion 330 and a part of first portion 110. Any configuration of first and second longitudinal constraining members, including partial or complete overlap of the two constraining members, is within the scope of the present disclosure. Further, the use of any number of longitudinal constraining members is within the scope of the present disclosure.
First longitudinal constraining member 104 and/or second longitudinal constraining member 334 can optionally be secured to porous tubular member 102, for example, to maintain the longitudinal constraining members in a desired orientation and position relative to porous tubular member 102. For example, first longitudinal constraining member 104 and/or second longitudinal constraining member 334 can be secured to porous tubular member 102 by applying an adhesive to a segment of an abluminal surface of porous tubular member 102 and/or the inner surface of the longitudinal constraining members. In various embodiments, a thermoplastic polymer adhesive, including a tetrafluoroethylene and perfluoromethyl vinyl ether copolymer, such as those described in U.S. Pat. No. 7,462,675 , can be used. In other embodiments, a fluoroelastomer adhesive, such as a FEP, can be used. Any means capable of securing first longitudinal constraining member 104 and/or second longitudinal constraining member 334 to first porous tubular member 102 is within the scope of the present disclosure.
A method for making a length extensible implantable device of the present disclosure is described as follows. A porous tubular member in a longitudinally uncompressed configuration is obtained and fitted coaxially over a mandrel having an outside diameter the same as or slightly larger than the inside diameter of the porous tubular member. The tubular member is longitudinally compressed by a compressive force so that the length of the tube is reduced to a desired length. A longitudinal constraining member is placed over at least a portion of the porous tubular member to maintain the portion of the member in the longitudinally compressed configuration. The longitudinal constraining member can optionally be secured to the porous tubular member. The compressive force on the porous tubular member is released, and the longitudinally compressed porous tubular member is removed from the mandrel.
Figs. 5A - 5D illustrate a porous tubular member in various stages of a method for forming the porous tubular member into a length extensible implantable device. For example, Fig. 5A illustrates porous tubular member 102 in an initial, longitudinally uncompressed configuration. In the longitudinally uncompressed configuration, porous tubular member 102 can comprise a length f1.
Fig. 5B illustrates porous tubular member 102 after a compressive force is applied. As the compressive force is applied, porous tubular member 102 is compressed from the initial, longitudinally uncompressed configuration to the longitudinally compressed configuration. In the longitudinally compressed configuration, porous tubular member 102 has a length ℓ2, which is shorter than f1. In various embodiments, porous tubular member 102 is biased such that, upon release of the compressive force, it will at extend from ℓ2 at least partially back to f1.
In various embodiments, ℓ2 can comprise a length that is between about 50% and 75% of ℓ1, such that compression from f1 to ℓ2 reduces the length of porous tubular member 102 to between 50% and 75% of its uncompressed length. In other embodiments, f2 can comprise a length that is between about 25% and 50% of f1. In yet other embodiments, ℓ2 can comprise a length that is between about 5% and 25% of f1. Any relationship between ℓ2 and f1 is within the scope of the present disclosure.
After porous tubular member 102 is compressed to a desired length ℓ2, at least one longitudinal constraining member 104 is applied around the abluminal surface of porous tubular member 102 to maintain at least a portion 110 of porous tubular member 102 in the longitudinally compressed configuration. For example, Fig. 5C illustrates porous tubular member 102 covered by longitudinal constraining member 104. In various embodiments, and as illustrated in Fig. 5C, portion 110 covered by longitudinal constraining member 104 can comprise the entire length (ℓ2) of porous tubular member 102. In other embodiments, portion 110 is less than the entire length of porous tubular members.
The longitudinal constraining member 104 comprises a film. In such embodiments, the film is wrapped around portion 110 of porous tubular member 102 in the longitudinally compressed configuration. As previously discussed, the film can be wrapped at a relatively low (about 0° to 45°) or a relatively high (about 45° to 90°) wrap angle relative to a longitudinal axis of porous tubular member 102. The film can also be wrapped at multiple angles, such as
embodiments in which multiple layers of film are wrapped in multiple directions along the abluminal surface of porous tubular member 102.
Further disclosed is a longitudinal constraining member 104 comprising a tubular element, such as a perforated tube. In such configurations, the tubular element is fitted along the surface of portion 110 of porous tubular member 102 in the longitudinally compressed configuration.
Longitudinal constraining member 104 can optionally be secured to porous tubular member 102. For example, an adhesive can be applied to the abluminal surface of porous tubular member 102. In other examples, an adhesive can be applied to the inner surface of longitudinal constraining member 104. However, as mentioned above, any manner of securing a longitudinal constraining member to a porous tubular member is within the scope of the present disclosure.
After portion 110 of porous tubular member 102 has been secured in the longitudinally compressed configuration by at least one longitudinal constraining member 104, the compressive force used to shorten porous tubular member 102 from f1 to ℓ2 can be relieved while longitudinal constraining member 104 maintains portion 110 in a compressed configuration, forming length extensible implantable device 100. If portion 110 comprises less than the entire length of porous tubular member 102, upon release of the compressive force, the segment of porous tubular member 102 not constrained can expand to its original length, leaving only portion 110 in the longitudinally compressed configuration. In embodiments in which the entirety length of porous tubular member 102 is covered by longitudinal constraining member 104 (in other words, where portion 110 is equal to ℓ2), all of porous tubular member 102 remains in the longitudinally compressed configuration.
In various embodiments, a second porous tubular member can be positioned around portion 110, portion 330, and or all of porous tubular member 102. In such configurations, longitudinal constraining members 104 and/or 334 are sandwiched between porous tubular member 102 and a second porous tubular member, such that longitudinal constraining members 110 and/or 330 cannot be seen when visually examining the outer surface of length extensible implantable device 100.
After length extensible implantable device 100 is formed, it can be adjusted and configured for use within the body of a patient. In various embodiments, as illustrated in Fig. 5D, the length of length extensible implantable device 100 can be expanded to a length ℓ3, which is greater than ℓ2 and less than or equal to the length of porous tubular member 102 in the initial, laterally uncompressed configuration (having a length of ℓ1). In various embodiments, as force is applied to porous tubular member 102, longitudinal constraining member 104 can rupture or tear, forming one or more ruptures 540. Once sufficient force is applied, porous tubular member 102 can continue expanding until it has expanded back to f1.
In various embodiments, portion 110 of porous tubular member 102 can be extended from the longitudinally compressed configuration to a longer length (such as f3) by applying a force parallel to the longitudinal axis of porous tubular member 102. In other embodiments, portion 110 of porous tubular member 102 can be extended from the longitudinally compressed configuration to ℓ3 by applying a radial force to portion 110.
For example, a treatment provider can determine a desired length of length extensible implantable device 100 before implanting the device into the vasculature of a patient. In other cases, the treatment provider can determine the desired length of length extensible implantable device 100 during the course of implanting the device into the vasculature and delivering the device to a treatment area of the patient.
Several characteristics and advantages have been set forth in the preceding description, including various alternatives together with details of the structure and function of the devices and methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive or limiting. It will be evident to those skilled in the art that various modifications may be made, especially in matters of structure, materials, elements, components, shapes, sizes, and arrangements of parts including combinations within the principles described herein, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed.

Claims

An implantable device (100) comprising:
a porous ePTFE member (102) comprising a longitudinally compressed portion (110) including bent fibrils;

a constraining member (104) covering at least a portion of the longitudinally compressed portion (110) thereby maintaining that portion in a longitudinally compressed configuration; and

wherein upon application of a sufficient elongating force to the porous ePTFE tubular member (102), the constraining member ruptures and permits elongation of the compressed portion, wherein upon release of the elongating force, the elongated compressed portion recovers to a shorter length.
A method for making an implantable device (100) comprising:
longitudinally compressing a porous ePTFE tubular member (102) to a longitudinally compressed configuration, wherein a microstructure of the porous ePTFE tubular member (102)

includes a multiplicity of fibrils, wherein a mean fibril length in the longitudinally compressed configuration is less than a mean fibril length prior to longitudinally compressing the porous member;

wrapping a film around at least a portion of a length of an abluminal surface of the porous ePTFE tubular member (102) as a constraining member (104) when the porous ePTFE tubular member (102) is in the longitudinally compressed configuration thereby maintaining that portion in a longitudinally compressed configuration; and wherein upon application of a sufficient elongating force to the porous ePTFE tubular member (102), the constraining member ruptures and permits elongation of the compressed portion, wherein upon release of the elongating force, the elongated compressed portion recovers to a shorter length.